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Early Weight Bearing in Unicondylar Tibial Plateau Fractures

Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does it Affect Gait Pattern, Mobility and Overall Outcome: A Randomized Controlled Trial

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06389240
Enrollment
60
Registered
2024-04-29
Start date
2022-12-21
Completion date
2028-12-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Mobilization

Keywords

unicondylar tibia plateau fractures, early mobilization, Gait analysis

Brief summary

The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

Detailed description

Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance. These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.

Interventions

OTHER6 weeks post-operatively early weight bearing

Early mobilization 6 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).

OTHER10 weeks post-operatively weight bearing (standard of care)

Standard of care mobilization at 10 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* Adult patients, at least 18 years of age, max 65 years of age * Unilateral tibial plateau fracture AO:41b/c * Written consent to participate (consent can be revoked at any time without giving reasons) * Surgery during the study period * Follow-up on-site (Salt Lake City, Utah, United States)

Exclusion criteria

* Multiple injured or polytraumatized patients * Other injuries or illnesses that impair the patient's mobility or gait * Cognitive limitations such as dementia, delirium or similar disease * Refusal to participate * Severe underlying disease with significant limitations in the ability to regenerate e.g. malignancies * Pathologic or osteoporotic fractures * Unable to attend clinic in person for follow-ups * pregnant women and fetus

Design outcomes

Primary

MeasureTime frameDescription
Average peak load (Newtons (N))6 weeks for early mobilization groupGait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJustin Haller, M.D.

University of Utah Orthopaedics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026